1. On October 22 and 23, 2013, the Cellular, Tissue, and Gene Therapy Advisory Committee of the United States Food and Drug Administration (FDA) will hold a public meeting to consider a request to move forward on a clinical trial of “mitochondrial replacement therapy” (MRT), a procedure that would involve the creation of “three-parent” babies. On March 20, 2013, regulatory authorities in the United Kingdom set it on a course to authorize MRT.

2. MRT is designed to help a small number of women affected by a rare form of mitochondrial disease have biologically-related children who are unaffected by the disease. MRT would work by inserting the nucleus of an egg of a woman who has unhealthy mitochondria into an enucleated egg (with healthy mitochondria) from another woman. This constructed egg would then be fertilized with sperm and the result would be a genetically modified “three-parent” baby.

The genetic modifications would not be limited to the child in whom the change is made; they would be passed on to all descendants of girls whose genome has been modified. Safer alternatives for women with mitochondrial defects to have healthy and biologically-related children are available.

3. MRT is a form of inheritable genetic modification (IGM), one of the most worrisome and  potentially consequential uses of new biotechnologies. Through IGM, scientists would manipulate the traits of future children.

4.  There is a long-standing international consensus that biotechnologies are to be used–with appropriate safeguards–to treat medical diseases, but are not to be used to manipulate the traits of future children.

5. Chief among the reasons for this international norm are:

a) to prevent the manipulation of the traits of future children through the use of biologically extreme procedures such as cloning and germ-line engineering;

b) these biologically extreme procedures are experimental and thus inherently unsafe for women, and the future generations of children who would carry these manipulated traits without their consent;

c) the use of such procedures could open the door to the creation of genetically modified “designer babies” and biotechnological eugenics; and

d) the creation of genetically modified designer babies would alter the relationship between parents and children, making children more like “manufactured products,” and could fundamentally alter the human species by effectively creating different classes of human beings–leading to the dissolution of our common humanity.

6. Inheritable genetic modification (IGM) is prohibited by the Charter of Fundamental Rights of the European Union, the Council of Europe’s Oviedo Convention on Biomedicine and Human Rights, the United Nations Education, Scientific, and Cultural Organization’s Universal Declaration on the Human Genome and Human Rights, and other instruments of international law.

7. If the United States and the United Kingdom permit these trials, they would allow the use of experimental procedures on human beings that have not been adequately tested for safety and efficacy. In addition, these procedures would present profound clinical, ethical, and social questions that have not yet been publicly addressed.

8.  With two of the world’s leading powers considering IGM, countries that now prohibit it will face increasing pressures to authorize it.

9. In light of these developments in the United States and the United Kingdom, there is a pressing need for global oversight with respect to IGM.

10. The world urgently needs the leadership of mothers, fathers, and others who care about the well-being of women, children, and the future of humanity to help:

a) convince the FDA to reject the request now pending before it; and

b) establish a moratorium on the use of IGM to allow for international public education, conversation, and decision-making on the appropriate global regulatory framework for IGM and other biotechnologies that could alter the human species.


imageEnola G. Aird is founder and director of Mothers for a Human Future. A former corporate lawyer, Aird  worked at the Children’s Defense Fund as Director of its Violence Prevention Campaign and Acting Director of its Black Community Crusade for Children. She is a past Chair of the Connecticut Commission on Children. She is a member of the Steering Committee of the Campaign for a Commercial-Free Childhood and an advisor to the Jamestown Project at Harvard. She and her husband, Stephen L. Carter, are the parents of two adult children.